Effectiveness of Levetiracetam in the Treatment of Body Dysmorphic Disorder

• ClinicalTrials.gov Identifier: NCT00265109
• Recruitment Status: Completed
• First Posted: December 14, 2005
• Results First Posted: November 16, 2010
• Last Update Posted: August 29, 2019
• Sponsor: Butler Hospital
• Collaborator: UCB Pharma
• Information provided by (Responsible Party): Butler Hospital

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Body Dysmorphic Disorder
• Intervention: Drug: Levetiracetam
• Enrollment: 17

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Period Title: Overall Study
Started	17
Completed	11
Not Completed	6
Reason Not Completed
Withdrawal by Subject	5
Adverse Event	1

Baseline Characteristics

Arm/Group Title		Open-Label Levetiracetam
Arm/Group Description		All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Overall Number of Baseline Participants		17
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	17 100.0%
	>=65 years	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	17 participants
		36.8 (10.2)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	17 participants
	Female	11 64.7%
	Male	6 35.3%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	17 participants
		17

Outcome Measures

1. Primary Outcome

Title	Number of Responders on the Yale-Brown Obsessive Compulsive Scale Modified for Body Dysmorphic Disorder (BDD-YBOCS)
Description	The BDD-YBOCS, a reliable and valid 12-item semi-structured clinician-administered scale assessed BDD severity during the past week. 38 items are rated from 0 (no symptoms) to 4 (extreme symptoms); range=0-48. This scale assesses preoccupation with the perceived appearance defects, associated compulsive behaviors, insight, and avoidance. A ≥30% decrease in total score indicated response.
Time Frame	Baseline to end week 12

Outcome Measure Data

Analysis Population Description

Analyses of the primary outcome measure were intention to treat (ITT) analyses.

Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description:	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Overall Number of Participants Analyzed	17
Measure Type: Count of Participants; Unit of Measure: Participants
	9 52.9%

2. Secondary Outcome

Title	Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Clinician Rating for BDD Symptoms
Description	The Clinical Global Improvement Scale (CGI) is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from "very much worse" (score of 7) to "very much improved" (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined improvement in BDD.
Time Frame	Last week of treatment (week 12) or last week of treatment for early dropouts

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Label
Arm/Group Description:	Open-label trial; all participants received levetiracetam Levetiracetam: The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.
Overall Number of Participants Analyzed	17
Measure Type: Count of Participants; Unit of Measure: Participants
	8 47.1%

3. Secondary Outcome

Title	Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Clinician Rating of Global Improvement.
Description	The CGI is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from "very much worse" (score of 7) to "very much improved" (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined global improvement.
Time Frame	Last week of treatment (week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Label
Arm/Group Description:	Open-label trial; all participants received levetiracetam Levetiracetam: The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.
Overall Number of Participants Analyzed	17
Measure Type: Count of Participants; Unit of Measure: Participants
	9 52.9%

4. Secondary Outcome

Title	Percentage of Participants Who Improved on the Body Dysmorphic Disorder Clinical Global Impressions Scale - Patient Rating for BDD Symptoms
Description	The Clinical Global Improvement Scale (CGI) is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from "very much worse" (score of 7) to "very much improved" (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined improvement in BDD.
Time Frame	Last week of treatment (week 12) or last week of treatment for early dropouts

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Label
Arm/Group Description:	Open-label trial; all participants received levetiracetam Levetiracetam: The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.
Overall Number of Participants Analyzed	17
Measure Type: Count of Participants; Unit of Measure: Participants
	8 47.1%

5. Secondary Outcome

Title	Percentage of Subjects Who Improved on the Clinical Global Improvement Scale (CGI) -- Patient Rating of Global Improvement.
Description	The CGI is a widely used 7-point scale that assesses global improvement or worsening of symptoms, with ratings ranging from "very much worse" (score of 7) to "very much improved" (score 1). Ratings of much improved (score of 2) or very much improved (score of 1) defined global improvement.
Time Frame	Last week of treatment (week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open Label
Arm/Group Description:	Open-label trial; all participants received levetiracetam Levetiracetam: The initial levetiracetam dose will be 250 mg/day, which will be increased to 250 mg BID after 1 week. The dose will then be increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose will be raised more slowly or the maximum dose will not be reached if response occurs at a lower dose or side effects are problematic. Subjects who are unable to tolerate at least 500 mg a day of levetiracetam will be withdrawn from the study.
Overall Number of Participants Analyzed	17
Measure Type: Count of Participants; Unit of Measure: Participants
	8 47.1%

6. Secondary Outcome

Title	Scores on Brown Assessment of Beliefs Scale
Description	The Brown Assessment of Beliefs Scale (BABS) is a 7-item semi-structured clinician-administered scale that assesses seven components of delusionality (insight) during the past week. Scores range from 0-24, with higher scores indicating greater delusionality. Beliefs are also categorized as delusional or nondelusional using an empirically derived cutpoint.
Time Frame	Pre- and post-treatment (week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description:	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Overall Number of Participants Analyzed	17
Mean (Standard Deviation); Unit of Measure: units on a scale
Pre-treatment	14.6 (4.3)
Post-treatment	10.4 (5.3)

7. Secondary Outcome

Title	Scores on Clinical Global Severity
Description	The 7-point Clinical Global Severity Scale assessed current illness severity at study baseline (score of 1=normal, not at all ill, and score of 7=among the most extremely ill patients).
Time Frame	Pre- and post-treatment (week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description:	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Overall Number of Participants Analyzed	17
Mean (Standard Deviation); Unit of Measure: units on a scale
Pre-treatment	5.2 (1.0)
Post-treatment	4.2 (1.6)

8. Secondary Outcome

Title	Scores on Hamilton Depression Rating Scale
Description	The 24-item Hamilton Rating Scale for Depression (HAM-D 24) is a widely used reliable and valid clinician-administered measure of current severity of depressive symptoms. Scores range from 0 to 76, with higher scores reflecting more severe depressive symptoms.
Time Frame	Pre- and post-treatment (week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description:	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Overall Number of Participants Analyzed	17
Mean (Standard Deviation); Unit of Measure: units on a scale
Pre-treatment	18.1 (6.4)
Post-treatment	11.4 (8.4)

9. Secondary Outcome

Title	Scores on Beck Anxiety Inventory
Description	The Beck Anxiety Inventory (BAI) is a reliable, valid, and widely used 21-item self-report measure of anxiety during the past week which focuses on somatic symptoms.44 The BAI has been shown to be sensitive to change. Scores range from 0-63, with higher scores reflecting more severe symptoms.
Time Frame	Pre- and post-treatment (week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description:	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Overall Number of Participants Analyzed	17
Mean (Standard Deviation); Unit of Measure: units on a scale
Pre-treatment	12.4 (6.8)
Post-treatment	9.6 (5.5)

10. Secondary Outcome

Title	Scores on Social Phobia Inventory
Description	The Social Phobia Inventory (SPIN) is a 17-item self-report questionnaire that assesses fear, avoidance, and physiological arousal associated with social anxiety during the past week. This scale is reliable, valid, and sensitive to change. Scores range from 0-68, with a score ≥19 distinguishing patients with social phobia from both healthy controls and psychiatric controls without social phobia.
Time Frame	Pre- and post-treatment (week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description:	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Overall Number of Participants Analyzed	17
Mean (Standard Deviation); Unit of Measure: units on a scale
Pre-treatment	32.9 (12.4)
Post-treatment	29.4 (13.8)

11. Secondary Outcome

Title	Scores on Global Assessment of Functioning
Description	The Global Assessment of Functioning (GAF) is a global measure of symptom severity and psychological, social, and occupational functioning. Scores range from 0-100, with lower scores denoting more severe illness and/or poorer functioning
Time Frame	Pre- and post-treatment (week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description:	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Overall Number of Participants Analyzed	17
Mean (Standard Deviation); Unit of Measure: units on a scale
Pre-treatment	46.1 (7.8)
Post-treatment	55.8 (14.5)

12. Secondary Outcome

Title	Scores on Social and Occupational Functioning Scale (SOFAS)
Description	The Social and Occupational Functioning Scale (SOFAS) is a global measure of psychological, social, and occupational functioning. Scores range from 0-100, with lower scores denoting more severe illness and/or poorer functioning
Time Frame	Pre- and post-treatment (week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description:	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Overall Number of Participants Analyzed	17
Mean (Standard Deviation); Unit of Measure: units on a scale
Pre-treatment	47.0 (8.5)
Post-treatment	59.8 (18.6)

13. Secondary Outcome

Title	Scores on The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) -- Short Form
Description	The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), Short Form, is a 14-item reliable and valid measure that is sensitive to change. Transformed scores range from 0 from 100, with lower scores reflecting poorer quality of life.The Short Form transformed score is reported.
Time Frame	Pre- and post-treatment (week 12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description:	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
Overall Number of Participants Analyzed	17
Mean (Standard Deviation); Unit of Measure: units on a scale
Pre-treatment	49.5 (10.3)
Post-treatment	57.4 (14.8)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Open-Label Levetiracetam
Arm/Group Description	All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
All-Cause Mortality
	Open-Label Levetiracetam
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Open-Label Levetiracetam
	Affected / at Risk (%)	# Events
Total	1/17 (5.88%)
Psychiatric disorders
Increased depression and suicidal ideation	1/17 (5.88%)	1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Open-Label Levetiracetam
	Affected / at Risk (%)	# Events
Total	12/17 (70.59%)
Psychiatric disorders
Fatigue †	8/17 (47.06%)	8
Irritability †	4/17 (23.53%)	4
Insomnia †	4/17 (23.53%)	4
Headache †	3/17 (17.65%)	3
Anxiety †	3/17 (17.65%)	3
Nausea †	2/17 (11.76%)	2
Dizziness †	2/17 (11.76%)	2
Feelings of Detachment †	1/17 (5.88%)	1
Agitation †	1/17 (5.88%)	1
Back Aches †	1/17 (5.88%)	1
Constipation †	1/17 (5.88%)	1
Decreased Libido †	1/17 (5.88%)	1
Diarrhea †	1/17 (5.88%)	1
Dyspepsia †	1/17 (5.88%)	1
Forgetfulness †	1/17 (5.88%)	1
Muscle Aches †	1/17 (5.88%)	1
Feeling Depressed †	1/17 (5.88%)	1
† Indicates events were collected by systematic assessment

Limitations and Caveats

This is a small open-label trial.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Katharine A. Phillips MD
• Organization: Weill Cornell Medicine
• Phone: 646-962-2820
• EMail: kap9161@med.cornell.edu

• Responsible Party: Butler Hospital
• ClinicalTrials.gov Identifier: NCT00265109
• Other Study ID Numbers: 0410-001
• First Submitted: December 12, 2005
• First Posted: December 14, 2005
• Results First Submitted: October 18, 2010
• Results First Posted: November 16, 2010
• Last Update Posted: August 29, 2019